List of Active Tox Labs Since FY '1990
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| Last Update
January 03, 2008 tf |
About
the List:
Nonclinical laboratory studies
are experiments in which test articles (food additives, color
additives, drug or biological products, electronic products,
medical devices for human use) are studied in test systems
(animals, plants, microorganisms, or subparts thereof) under
laboratory conditions to determine their safety.
The Food and Drug Administration (FDA) regulates the conduct
of nonclinical laboratory studies under Part 58 (Good Laboratory
Practice for Nonclinical Laboratory Studies) of Title 21 of
the Code of Federal Regulations. FDA inspects facilities that
conduct nonclinical laboratory studies to determine the facilities
compliance with part 58.
The following is a list of the testing facilities that have
been inspected since October 1, 1989. The list provides the
current name and former (if known) names of the testing facility,
the dates the facility has been inspected, and the classification
of the inspection results (see description below).
The inspection dates may not be in chronological order because
the inspection assignments are issued on a quarterly basis
and reports may not have been entered in chronological order.
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Contact:
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Ruark Lanham
MSODL Investigator / Program Expert
Bioresearch Monitoring
Division of Field Investigations, HFC0-130
Office of Regulatory Affairs
US Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Phone: (301) 827 - 6691
Electronic mail: Ruark.Lanham@fda.hhs.gov
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Inspection
Classification Codes :
CAN: Canceled
NAI: No Action Indicated. No objectionable conditions
or practices were found during the inspection (or the objectionable
conditions found do not justify further regulatory action).
NCC: Non Classified
NIM: No Inspection Made.
OAI: Official Action Indicated. Regulatory and
administrative actions will be recommended.
PEN: Pending review and classification.
RTC: Refer to Center: Establishment Inspection
Report had been forwarded to Center for final review and
classification.
VAI: Voluntary Action Indicated. Objectionable
conditions or practices were found, but the agency is not
prepared to take or recommend any administrative or regulatory
action.
WO: Washout: Firm was visited or inspected, however,
not performing regulated studies at time of inspection.
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Classification
Codes No Longer in Use:
VAI-1: Establishment has made voluntary corrections
in such a manner that the objectionable conditions are not
likely to recur and routine reinspection is indicated.
VAI-2: Establishment advised by investigator or
other district communication of objectionable conditions
that should be corrected; however, the significance is such
that routine reinspection is indicated.
VAI-3: Objectionable conditions do not justify
official action at this time but the evidence shows that
the conditions, if not corrected, could reasonably result
in or lead to conditions that would support official action.
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Miscellaneous
Abbreviations:
dba: Doing Business As.
fka: Formerly Known As - Former
name(s) of the establishment.
OOB: Establishment is Out of Business
as a nonclinical laboratory.
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List
of Active Tox Labs (since FY '1990) |
- A - |
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| Laboratory |
Date
Inspected |
Class
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AAI Development Services
fka: AAI International
(fka: Kansas City Analytical)
Shawnee, KS |
04-22-96 |
VAI |
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09-13-99 |
OAI |
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07-23-01 |
NAI |
|
03-18-03 |
NAI |
| |
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ABC Laboratories
(Analytical Bio-Chem) Columbia, MO |
09-06-94 |
VAI |
| |
04-22-96 |
NAI |
| |
10-22-02 |
NAI |
| |
06-07-04 |
VAI |
| |
06-27-06 |
PEN |
| |
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Abbott Laboratories
North Chicago, IL |
02-25-91 |
VAI-2 |
|
07-22-91 |
NAI |
|
09-08-93 |
NAI |
|
07-23-97 |
NAI |
|
10-27-97 |
NAI |
|
05-21-03 |
NAI |
| |
09-21-05 |
NAI |
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Advion BioSciences, Inc fka:Advanced
Bioanalytical Services
Ithaca, NY |
03-12-98 |
NAI |
|
12-03-02 |
NAI |
| |
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Alcon Labs
Ft. Worth, TX |
07-19-93 |
VAI-2 |
| |
10-22-97 |
VAI |
| |
12-13-99 |
VAI |
| |
05-21-02 |
VAI |
| |
08-24-04 |
NAI |
| |
07-20-06 |
PEN |
| |
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| Allergan Pharmaceutical Irvine, CA
|
06-11-91 |
VAI-2 |
| |
08-26-93 |
NAI |
| |
03-27-96 |
NAI |
| |
04-07-98 |
NAI |
| |
09-20-00 |
NAI |
| |
11-18-02 |
VAI |
| |
04-19-05 |
NAI |
| |
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Alpharma, Inc
fka: A.L. Labs Inc
Chicago Hgts, IL |
11-17-89 |
WO |
| |
05-15-03 |
NAI |
| |
09-26-05 |
PEN |
| |
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Alta Analytical Laboratory
San Diego , CA |
02-26-04 |
VAI |
| |
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Alza Corporation
Mountain View, CA |
11-12-91 |
NAI |
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11-17-93 |
NAI |
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12-09-98 |
NAI |
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10-28-02 |
NAI |
| |
06-07-05 |
NCC |
| |
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American Cardiovascular Res Inst
fka: Atlanta Cardiology
Norcross, GA |
04-28-03 |
OAI |
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03-01-04 |
VAI |
| |
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Amgen, Inc.
Thousand Oaks, CA |
09-16-98 |
NAI |
| |
07-23-02 |
VAI |
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08-24-04 |
NAI |
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Ani Lytics, Inc.
Gaithersburg, MD |
02-24-94 |
NAI |
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08-10-99 |
VAI |
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12-03-02 |
NAI |
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AppTec Laboratory Services
St. Paul, MN |
12-04-03 |
VAI |
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Aptuit Inc
fka: Quintiles Inc
Kansas City, MO
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08-21-03 |
VAI |
| |
04-04-05 |
NAI |
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AstraZeneca Pharmaceuticals
Wilmington, DE |
02-11-04 |
NAI |
| |
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Atrix Labs
Ft. Collins, CO |
11-06-97 |
VAI |
| |
10-23-03
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VAI |
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- B - |
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BAS Evansville
fka:Toxicology & Pathology Serv
Mt. Vernon, IN |
01-08-90 |
NAI |
| |
03-11-92 |
NAI |
| |
05-10-93 |
VAI-2 |
| |
10-11-94 |
NAI |
| |
09-19-95 |
NAI |
| |
07-22-96 |
NAI |
| |
06-21-99 |
NAI |
| |
07-23-01 |
NAI |
| |
09-15-03
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NAI |
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04-20-05
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PEN |
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BASi Northwest Lab Serv
McMinnville, OR |
08-02-04 |
NAI |
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Battelle Memorial Institute
Columbus, OH |
12-07-92 |
VAI-2 |
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01-09-95 |
VAI |
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08-01-95 |
VAI |
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02-09-98 |
VAI |
| |
04-18-00 |
VAI |
| |
03-25-02 |
VAI |
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12-09-02 |
VAI |
| |
01-06-04 |
VAI |
| |
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Battelle Memorial Institute
W. Jefferson, OH |
05-23-94 |
OAI |
| |
06-16-95 |
NAI |
| |
10-30-96 |
VAI |
| |
03-30-99 |
VAI |
| |
07-30-01 |
VAI |
| |
02-17-04 |
VAI |
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08-02-04 |
VAI |
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01-25-06 |
VAI |
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Battelle Pacific NW
fka: Battelle Toxicology
Richland, WA |
08-10-92 |
NAI |
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01-23-95 |
VAI |
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12-16-96 |
NAI |
| |
12-07-98 |
VAI |
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11-13-00 |
NAI |
| |
07-28-03
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NAI |
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Baxter Healthcare
Round Lake, IL |
07-07-94 |
NAI |
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01-31-00 |
NAI |
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Bay Bioanalytical Lab
Hercules, CA |
11-05-03 |
NAI |
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Bayer CropScience LP
Fka: Bayer Corporation
Stilwell, KS |
04-22-96 |
VAI |
| |
09-11-98 |
NAI |
| |
07-17-00 |
NAI |
| |
08-22-02 |
NAI |
| |
04-14-04 |
NAI |
| |
04-18-05 |
VAI |
| |
09-26-06 |
PEN |
| |
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B. Braun Medical Inc
fka: B. Braun McGaw
dba: Biological Test Center
Irvine, CA |
07-09-91 |
VAI-2 |
| |
09-30-93 |
NAI |
| |
08-02-96 |
NAI |
| |
09-08-98 |
NAI |
| |
03-13-01 |
NAI |
| |
08-02-04 |
NAI |
| |
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Becton Dickinson
Res Tri Pk, NC |
11-12-92 |
NAI |
| |
05-19-98 |
VAI |
| |
12-06-00 |
NAI |
| |
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Biocon, Inc.
Rockville, MD |
11-09-98 |
VAI |
| |
04-25-01 |
NAI |
| |
09-08-03 |
NAI |
| |
08-23-05 |
VAI |
| |
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| Bio Development Assoc Mountlake
Terrace, WA formerly Bellevue, WA |
11-10-03 |
OAI |
| |
08-01-06 |
PEN |
| |
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Bio Devices Lab
Orange, CA |
10-25-96 |
NAI |
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01-26-04 |
VAI |
| |
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| Biologic Safety Research Maywood,
IL |
02-09-99 |
NAI |
| |
04-23-03 |
OAI |
| |
09-08-05 |
PEN |
| |
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BioMedical Res Found of South Texas
San Antonio, TX |
06-27-02 |
NAI |
| |
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Bioqual Inc
Rockville, MD |
09-10-03 |
VAI |
| |
11-07-05 |
PEN |
| |
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BioReliance Invitrogen Bioservices
fka: BioReliance Corp.
fka: MA BioServices, Inc.
fka: Microbiological Assoc.
Rockville, MD |
09-27-93 |
NAI |
| |
05-24-99 |
NAI |
| |
06-18-01 |
VAI |
|
07-18-03
|
NAI |
| |
09-29-05 |
VAI |
| |
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Biosynexus Inc
Gaithersburg, MD |
02-17-04 |
VAI |
| |
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Biotechnics Inc
Hillsborough, NC |
11-12-03 |
NAI |
| |
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Boehringer Ingelheim
Ridgefield, CT |
06-12-95 |
NAI |
| |
11-02-95 |
NAI |
| |
09-28-98 |
VAI |
| |
01-03-01 |
VAI |
| |
06-04-03 |
VAI |
| |
09-27-05 |
PEN |
| |
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Boehringer Ingelheim
Vetmedica
St. Joseph, MO |
03-20-90 |
VAI-2 |
| |
02-23-94 |
NAI |
| |
03-11-03 |
NAI |
| |
07-11-05 |
NAI |
| |
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Bristol-Myers Squibb Co
Syracuse, NY |
09-10-90 |
VAI-2 |
| |
10-30-92 |
VAI-3 |
| |
10-18-93 |
NAI |
| |
01-10-96 |
NAI |
| |
03-26-98 |
NAI |
| |
03-01-00 |
VAI |
| |
03-19-02 |
VAI |
| |
06-07-04 |
NAI |
| |
08-02-06 |
PEN |
| |
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Bristol-Myers Squibb
Mt. Vernon, IN |
06-05-91 |
NAI |
| |
10-13-92 |
VAI-1 |
| |
06-30-93 |
NAI |
| |
07-22-96 |
NAI |
| |
01-13-99 |
NAI |
| |
08-06-01 |
NAI |
| |
06-24-03 |
NAI |
| |
08-22-05 |
PEN |
| |
|
|
| Bristol-Myers Squibb Co New
Brunswick, NJ |
09-17-90 |
NAI |
| |
07-17-91 |
VAI-2 |
| |
12-03-91 |
VAI-2 |
| |
10-19-92 |
VAI-2 |
| |
11-29-93 |
VAI |
| |
02-13-95 |
NAI |
| |
10-24-95 |
NAI |
| |
02-10-97 |
NAI |
| |
04-25-99 |
NAI |
| |
01-24-00 |
VAI |
| |
04-26-01 |
NAI |
| |
03-06-03 |
VAI |
| |
09-06-05 |
NAI |
| |
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Bristol-Myers Squibb Co
Lawrenceville, NJ |
10-07-02 |
NAI |
| |
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Bristol-Myers Squibb Co
Pennington, NJ |
10-09-02 |
NAI |
| |
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Burleson Res Technologies
Raleigh, NC |
06-22-04 |
VAI |
| |
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- C - |
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California National Primate Res Center
Davis, CA |
12-10-90 |
NAI |
| |
08-13-91
|
NAI |
| |
10-27-03
|
NAI |
| |
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Calvert Laboratories Inc
fka: Calvert Preclinical Service
fka: Phoenix International
fka: Chrysalis Preclin.
fka: Pharmakon
Olyphant, PA |
11-13-90 |
NAI |
| |
01-27-92 |
NAI |
| |
01-04-93 |
NAI |
| |
11-15-93 |
NAI |
| |
10-31-95 |
VAI |
| |
01-06-98 |
NAI |
| |
03-06-00 |
VAI |
| |
03-04-02 |
VAI |
| |
08-23-04 |
NAI |
| |
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Cardinal Health
Magellan Laboratories
Morrisville, NC |
08-23-00 |
NAI |
| |
01-07-02 |
NAI |
| |
05-24-04 |
NAI |
| |
06-19-06 |
PEN |
| |
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Cardionome Laboratories
Located @ N. Dakota State Univ
Fargo, ND |
06-24-04 |
NAI |
| |
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CAVL, Inc. & CRC
aka: Central Arizona Vet Lab
(Clymer, William)
Amarillo, TX |
06-19-91 |
NAI |
| |
03-14-95 |
NAI |
| |
05-06-03 |
VAI |
| |
06-02-05 |
NAI |
| |
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| Cedars-Sinai Med Cen Los Angeles,
CA |
09-13-06 |
PEN |
| |
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CEDRA Corporation
Austin, TX |
07-16-03 |
NAI |
| |
08-31-05 |
NAI |
| |
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Celsis Laboratory Group
fka: Leberco
Edison, NJ
|
09-08-99 |
NAI |
| |
07-17-01 |
VAI |
| |
04-02-04 |
NIM |
| |
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ChanTest Inc
Cleveland, OH |
09-13-04 |
NAI |
| |
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Charles River Laboratories
Wilmington, MA |
07-23-03 |
VAI |
| |
05-26-05 |
VAI |
| |
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Charles River Laboratories Preclinical
Services, Massachusetts
fka: Primedica Corp.
fka: GTC Mason Laboratories
fka: TSI Mason
aka: Transgenic Science Inc
Worcester, MA |
12-03-90 |
VAI-2 |
| |
11-25-91 |
NAI |
| |
11-16-92 |
VAI-2 |
| |
11-28-94 |
VAI |
| |
06-30-97 |
VAI |
| |
11-03-97 |
VAI |
| |
05-03-99 |
VAI |
| |
03-27-00 |
VAI |
| |
07-18-01 |
VAI |
| |
09-08-03
|
VAI |
| |
09-20-05 |
NAI |
| |
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Charles River Laboratories Preclinical
Services Pennsylvania
fka: Primedica Corp, Argus Res
Horsham, PA |
04-15-92 |
NAI |
| |
05-25-93 |
NAI |
| |
02-21-95 |
NAI |
| |
03-11-96 |
NAI |
| |
10-20-97 |
NAI |
| |
01-26-01 |
NAI |
| |
09-02-03 |
NAI |
| |
12-15-04 |
NAI |
| |
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Charles River Laboratories Preclinical
Services Arkansas
fka: Primedica Redfield Labs
fka: GTC Mason
fka: TSI Redfield Labs
Redfield, AR |
04-28-92 |
NAI |
| |
08-08-94 |
NAI |
| |
09-08-97 |
VAI |
| |
01-25-99 |
NAI |
| |
04-09-01 |
VAI |
| |
04-16-02 |
VAI |
| |
07-27-04 |
NAI |
| |
09-25-06 |
PEN |
| |
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Charles River Laboratories Preclinical
Services Ohio
fka: Springborn Labs
Spencerville, OH
|
11-02-92 |
NAI |
| |
10-07-93 |
NAI |
| |
08-15-94 |
VAI |
| |
11-06-95 |
VAI |
| |
01-06-97 |
VAI |
| |
04-14-97 |
NAI |
| |
05-24-99 |
VAI |
| |
01-24-00 |
VAI |
| |
07-31-01 |
NAI |
| |
07-31-01 |
VAI |
| |
07-28-03 |
VAI |
| |
08-17-04 |
NAI |
| |
|
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Charles River Laboratories Pathology
Associates Ohio
West Chester, OH
|
11-08-99 |
NAI |
| |
05-13-03 |
NAI |
| |
|
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Charles River Laboratories Preclinical Services,
Nevada
fka: Sierra Biomedical Div
Sparks, NV
|
10-18-93 |
VAI |
| |
10-28-97 |
VAI |
| |
06-12-00 |
NAI |
| |
06-06-01 |
NAI |
| |
12-03-02 |
VAI |
| |
06-30-04 |
NAI |
| |
09-14-05 |
PEN |
| |
|
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Charles River Laboratories
Pathology Associates, Colorado
Boulder, CO
|
06-16-05 |
NAI |
| |
|
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Charles River Laboratories
Pathology Associates, N. Carolina
(formerly in Durham)
Cary, NC
|
06-01-04 |
NAI |
| |
08-15-06 |
PEN |
| |
|
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Charles River Laboratories Pathology Associates,
Illinois
Chicago, IL
|
09-16-98 |
NAI |
| |
06-05-01 |
VAI |
| |
09-27-04 |
NAI |
| |
|
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Charles River Laboratories Pathology Associates,
Maryland
Frederick, MD
|
04-13-92 |
NAI |
| |
05-23-94 |
NAI |
| |
09-23-99 |
NAI |
| |
07-24-01 |
NAI |
| |
06-26-03 |
NAI |
| |
05-25-06 |
PEN |
| |
|
|
Charles River Laboratories Pathology Associates,
Missouri
Kansas City, MO
|
05-03-01 |
NAI |
| |
02-14-03 |
NAI |
| |
02-27-06 |
NAI |
| |
|
|
ChemPharma International
Richmond, KY
|
09-21-05 |
NAI |
| |
|
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Clinical Microbiology Inst
Wilsonville, OR |
02-23-04 |
VAI |
| |
|
|
Colorado Histo-Prep
Fort Collins, CO |
03-26-92 |
NAI |
| |
04-06-94 |
NAI |
| |
06-16-97 |
NAI |
| |
07-09-01 |
NAI |
| |
|
|
Colorado Pathology Serv
Collbran, CO |
09-20-93 |
NAI |
| |
06-01-98 |
NAI |
| |
08-01-01 |
NAI |
| |
03-07-05 |
NAI |
| |
|
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Colorado Quality Research
Fort Collins, CO |
11-02-95 |
NAI |
| |
02-28-01 |
NAI |
| |
01-27-04 |
VAI |
| |
|
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Comparative Biosciences
Mountain View, CA |
04-06-04 |
VAI |
| |
07-18-06 |
PEN |
| |
|
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Consumer Product Testing
Fairfield, NJ |
11-19-90 |
OAI |
| |
05-21-91 |
NAI |
| |
03-18-93 |
VAI-2 |
| |
10-18-94 |
VAI |
| |
11-12-96 |
NAI |
| |
01-08-99 |
VAI |
| |
03-15-01 |
VAI |
| |
09-16-03 |
VAI |
| |
|
|
Cordis Corporation
Warren, NJ |
06-10-02 |
VAI |
| |
|
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Covance Laboratories, Inc.
fka: Corning Hazleton
Vienna, VA |
01-25-90 |
NAI |
| |
09-11-90 |
NAI |
| |
03-09-92 |
VAI-2 |
| |
09-08-92 |
VAI-2 |
| |
08-17-93 |
NAI |
| |
10-12-94 |
VAI |
| |
08-05-97 |
NAI |
| |
04-08-98 |
NAI |
| |
09-28-98 |
NCC |
| |
07-12-00 |
VAI |
| |
10-30-00 |
VAI |
| |
06-17-02 |
VAI |
| |
12-17-02 |
NAI |
| |
05-31-05 |
VAI |
| |
|
|
Covance Laboratories Inc.
fka: Corning Hazleton
Madison, WI |
04-16-90 |
VAI-2 |
| |
09-11-90 |
VAI-2 |
| |
03-11-91 |
NAI |
| |
08-19-91 |
VAI-2 |
| |
09-11-91 |
NAI |
| |
08-17-92 |
NAI |
| |
08-02-93 |
NCC |
| |
08-16-93 |
VAI-2 |
| |
11-08-94 |
VAI |
| |
09-11-95 |
NCC |
| |
09-25-95 |
NAI |
| |
05-20-96 |
NCC |
| |
03-17-97 |
NAI |
| |
11-10-98 |
VAI |
| |
03-27-00 |
VAI |
| |
07-18-00 |
VAI |
| |
04-02-01 |
VAI |
| |
05-28-03 |
NAI |
| |
01-13-05 |
VAI |
| |
|
|
Covance Research Animals
fka: HRP Inc
fka: Hazleton Research Products
fka: Hazleton Lab Res Enterprise
Kalamazoo, MI |
07-06-04 |
NAI |
| |
05-31-06 |
NIM |
| |
|
|
- D - |
|
| |
|
|
Discovery Laboratories Inc
Warrington, PA |
12-06-04 |
VAI |
| |
|
|
Dow Corning Corp
Midland, MI |
11-13-89 |
VAI-2 |
| |
08-07-90 |
VAI-2 |
| |
11-23-92 |
NAI |
| |
11-05-02 |
NAI |
| |
|
|
- E - |
|
| |
|
|
Edwards Lifesciences LLC
fka: Baxter Edwards
Irvine, CA |
06-18-91 |
NAI |
| |
06-02-04 |
PEN |
| |
|
|
Enthalpy Analytical
Durham, NC |
04-13-04 |
NIM |
| |
|
|
| EPL Archives Inc Sterling, VA |
08-11-06 |
PEN |
| |
|
|
Equi-Tox Inc
Central, SC |
11-29-00 |
VAI |
| |
06-21-04 |
NAI |
| |
|
|
Ethicon ENDO Surgery
Cincinnati, OH |
05-20-02 |
VAI |
| |
08-23-05 |
NAI |
| |
|
|
Eurofins Scientific Inc
dba: Product Safety Labs
E. Brunswick, NJ |
04-22-91 |
VAI-2 |
| |
09-03-92 |
VAI-2 |
| |
01-12-95 |
VAI |
| |
09-22-97 |
NAI |
| |
09-27-99 |
NAI |
| |
07-23-01 |
NAI |
| |
09-29-03 |
NAI |
| |
09-07-05 |
VAI |
| |
|
|
Eurofins Scientific Inc
dba: Product Safety Labs Dayton, NJ |
07-23-01 |
VAI |
| |
09-22-03 |
VAI |
| |
08-31-05 |
VAI |
| |
|
|
Experimental Pathology Labs
Durham, NC |
10-29-92 |
NAI |
| |
12-17-96 |
NAI |
| |
11-20-00 |
VAI |
| |
11-16-04 |
NAI |
| |
|
|
Experimental Pathology Labs
Sterling, VA |
04-22-96 |
NCC |
